Dockets Entered on May 9, 2006

Dockets Management



Dockets Entered On May 9, 2006



Docket #	Title

2004N-0408	Regulatory Site Visit Training Program

2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

2006D-0083	Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

2006D-0169	Guidance for Industry: Guidance on the labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Availability

2006N-0045	Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT); Public Workshop; Request for Comments

2006P-0101	Petition for Review of Codex Standard for Honey Under 21 CFR 130.6

2006P-0124	Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules

2006P-0126	Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

2006P-0173	Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product

2006V-0194	Laser Light Show

2004N-0408	Regulatory Site Visit Training Program

EC 16	Life Sera	Vol #:	1

EC 17	Lovelace Respiratory Research Institute	Vol #:	1

EC 18	University of Utah Cell Therapy Facility	Vol #:	1

EC 19	Cleveland Eye Bank	Vol #:	1

EC 20	Introgen Therapeutics, Inc.	Vol #:	1

EC 21	Donor Network of Arizona	Vol #:	1

EC 22	Biogen Idec	Vol #:	1

EC 23	Community Blood Center of the Ozarks	Vol #:	1

EC 24	Minnesota Lions Eye Bank	Vol #:	1

EC 25	Hoag Cancer Center	Vol #:	1

2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing

EC 1	ECRI	Vol #:	1

EC 2	Dr. Hansel de Sousa	Vol #:	1

EC 3	Mr. Shannon Bennett	Vol #:	1

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

C 8442	E. Supica	Vol #:	127

C 8443	J. L.. Liodsey	Vol #:	127

C 8444	B. I Peeh	Vol #:	127

C 8445	M. J. Heil	Vol #:	127

C 8446	M. Alexander	Vol #:	127

C 8447	E. Fortier	Vol #:	127



C 8448	T. Roller	Vol #:	127

C 8449	C. B. Daigle	Vol #:	127

C 8450	K. Zriny	Vol #:	127

C 8451	N. Radocka	Vol #:	127

C 8452	E. B. Paulson	Vol #:	127

C 8453	G. Taylor	Vol #:	127

C 8454	K. Ruiz	Vol #:	127

C 8455	S. Yost	Vol #:	127

C 8456	J. Morse	Vol #:	127

C 8457	D. Hansen	Vol #:	127

C 8458	P. Wilih	Vol #:	127

C 8459	F. Krause	Vol #:	127

C 8460	FJ. Boelzner	Vol #:	127

C 8461	M. Mancuso	Vol #:	127

C 8462	C. Fondren	Vol #:	127

C 8463	E. Winsor	Vol #:	127

C 8464	W. Wilson	Vol #:	127

C 8465	J. Nybers	Vol #:	127

C 8466	K. Poe	Vol #:	127

C 8467	T. Manll	Vol #:	127

C 8468	P. DiSaia	Vol #:	127

C 8469	B. Silverstein	Vol #:	127

C 8470	J. German	Vol #:	127

C 8471	A. Rarola	Vol #:	127

C 8472	B. E. Gil	Vol #:	127

C 8473	S. Shelley	Vol #:	127

C 8474	W. Guerrero	Vol #:	127

C 8475	K. Hudak	Vol #:	127

C 8476	K.Meyer	Vol #:	127

C 8477	B. B. Venile	Vol #:	127

C 8478	L. J. Myers	Vol #:	127

C 8479	R. E. Myers	Vol #:	127

C 8480	M. McGulis	Vol #:	127

C 8481	E. Eden	Vol #:	127

C 8482	J. McPherson	Vol #:	127

C 8483	E. V. Washing	Vol #:	127

C 8484	D. ODell	Vol #:	127



C 8485	L. O'Dell	Vol #:	127

C 8486	K. L. Johnson	Vol #:	126

C 8487	J. Knutson	Vol #:	127

C 8488	N. Rolls	Vol #:	127

C 8489	P. Codit	Vol #:	127

C 8490	D. Nielson	Vol #:	127

C 8491	P. Alexader	Vol #:	127

C 8492	P. Alexader	Vol #:	127

C 8493	E. D. Phillips	Vol #:	127

C 8494	A. Miller	Vol #:	127

C 8495	H. Leo	Vol #:	127

C 8496	J. Pero	Vol #:	127

C 8497	N. M. Dolan	Vol #:	127

C 8498	E. T. Lewis	Vol #:	127

C 8499	L. J. Arcade	Vol #:	127

C 8500	L. Connedy, MD	Vol #:	127

C 8501	B. AnnLee	Vol #:	127

C 8502	C. Downing	Vol #:	127

C 8503	C. Downing	Vol #:	127

C 8504	I J. Tyner	Vol #:	127

C 8505	E. T. Lewis	Vol #:	127

C 8506	E. T. Lewis	Vol #:	127

C 8507	P. Hale	Vol #:	127

C 8508	S. Clark	Vol #:	127

C 8509	S . Moore	Vol #:	127

C 8510	L. J. Arcode	Vol #:	127

C 8511	L. Connedy, MD	Vol #:	127

C 8512	B. Ann Lee	Vol #:	127

C 8513	C. Downing	Vol #:	127

C 8514	I. J. Tyner	Vol #:	127

C 8515	I. J. Tyner	Vol #:	127

C 8516	D. Buters	Vol #:	127

C 8517	M. Goldman	Vol #:	127

C 8518	R. R. Tschopp	Vol #:	127

C 8519	C. Peterson	Vol #:	127

C 8520	J. Schierhole	Vol #:	127

C 8521	J. Rohlf	Vol #:	127



C 8522	J. G. Meyer	Vol #:	127

C 8523	M. Rickerk	Vol #:	127

C 8524	J. Ingalls, MD	Vol #:	127

C 8525	D. Schofer	Vol #:	127

C 8526	K. Tegethoff	Vol #:	127

C 8527	T. Rivera	Vol #:	127

C 8528	J. Gjerde	Vol #:	127

C 8529	C. Lonex	Vol #:	127

C 8530	R. Wells	Vol #:	127

C 8531	D. Sato	Vol #:	127

C 8532	Unreadabl	Vol #:	127

C 8533	M. A. Seymour	Vol #:	127

C 8534	T. Kramer	Vol #:	127

C 8535	S. Livermore	Vol #:	127

C 8536	R. DeSilva	Vol #:	127

C 8537	F. Murphy	Vol #:	127

C 8538	D. Lewman	Vol #:	127

C 8539	S. Hoffman	Vol #:	127

C 8540	T. Goenbeg	Vol #:	127

C 8541	Unreadable	Vol #:	127

C 8542	L. N. Downs	Vol #:	127

C 8543	N. F. Neimark, MD	Vol #:	127

C 8544	J. Lehman	Vol #:	127

C 8545	E. Cathey	Vol #:	127

C 8546	D. R. Stoyer	Vol #:	127

C 8547	P. AnGrace	Vol #:	127

C 8548	J. Sanehira	Vol #:	127

C 8549	R. C. Compton	Vol #:	127

C 8550	G. Rasmussen	Vol #:	127

C 8551	S. Tueli	Vol #:	127

C 8552	L. Welp	Vol #:	127

C 8553	J. Rohlf	Vol #:	127

C 8554	C. Ludwig	Vol #:	127

C 8555	L. G. Morgan	Vol #:	127

C 8556	C. LaGrou	Vol #:	127

C 8557	D. M. Manning	Vol #:	127

C 8558	M. Michelson	Vol #:	127



C 8559	A. Glasscock	Vol #:	129

C 8560	T. Allweil	Vol #:	127

C 8561	D. Vogler	Vol #:	127

C 8562	R. Sumegi	Vol #:	127

C 8563	S. Boehms	Vol #:	127

C 8564	P. J. Klissig	Vol #:	127

C 8565	E. Scheyer	Vol #:	127

C 8566	J. <cCullough	Vol #:	127

C 8567	C. Williams	Vol #:	127

C 8568	K. Hirsch	Vol #:	127

C 8569	J. Hock	Vol #:	127

C 8570	P. Noll	Vol #:	127

C 8571	P. Rippel	Vol #:	127

C 8572	H. Maxey	Vol #:	127

C 8573	S. Morse	Vol #:	127

C 8574	P. Lagattuta	Vol #:	127

C 8575	L. Murphy	Vol #:	127

C 8576	J. O'Neil	Vol #:	127

C 8577	O. O. Garza	Vol #:	127

C 8578	K. Rost	Vol #:	127

C 8579	S. R. Davis	Vol #:	127

C 8580	J. Treacy	Vol #:	127

C 8581	R. Hass	Vol #:	127

C 8582	zl. McLain	Vol #:	127

C 8583	H. Kelly	Vol #:	127

C 8584	C. Cunningham	Vol #:	127

C 8585	P. Egan	Vol #:	127

C 8586	D. Mull	Vol #:	127

C 8587	W. A. Rose	Vol #:	127

C 8588	B. Summer	Vol #:	127

C 8589	A Berger, MD	Vol #:	127

C 8590	A. J. Soult, MD	Vol #:	128

C 8591	D. Grandos	Vol #:	128

C 8592	E. Loetterle	Vol #:	128

C 8593	B. Sova	Vol #:	128

C 8594	G. Duncan	Vol #:	128

C 8595	K. Hernandez	Vol #:	128



C 8596	E. Wetter	Vol #:	128

C 8597	C. Weaver	Vol #:	128

C 8598	J. Kinsy	Vol #:	128

C 8599	B. McDougah	Vol #:	128

C 8600	R. Happy Rons	Vol #:	128

C 8601	M. Lincolin	Vol #:	128

C 8602	T. Vestal	Vol #:	128

C 8603	E. J. Cartmill	Vol #:	128

C 8604	B. Schneider	Vol #:	128

C 8605	D. M. Rames	Vol #:	128

C 8606	K. L. Griffith	Vol #:	128

C 8607	N. C. SLewis	Vol #:	128

C 8608	J. Peterson	Vol #:	128

C 8609	A. Gonzales	Vol #:	128

C 8610	D. Stacey	Vol #:	128

C 8611	M. R. Dinardo	Vol #:	128

C 8612	D. J. Peterson	Vol #:	128

C 8613	S. Swartz	Vol #:	128

C 8614	S. S. Zarcone	Vol #:	128

C 8615	M. K. Danley	Vol #:	128

C 8616	J. Rosenberg	Vol #:	128

C 8617	D. Sampson	Vol #:	128

C 8618	S. Williams-Andrews	Vol #:	128

C 8619	L. M. Schulte	Vol #:	128

C 8620	M. Moffat	Vol #:	128

C 8621	J. Kennedy	Vol #:	128

C 8622	A. Doorn	Vol #:	128

C 8623	D. Collins	Vol #:	128

C 8624	J. Bowman	Vol #:	128

C 8625	P. Ratliff	Vol #:	128

C 8626	B. Beaman	Vol #:	128

C 8627	B. J. Blecha	Vol #:	128

C 8628	K. Stienstra	Vol #:	128

C 8629	S. Gilbert	Vol #:	128

C 8630	D. Byster	Vol #:	128

C 8631	N. Long	Vol #:	128

C 8632	L. Willimon	Vol #:	128



C 8633	J. Herr	Vol #:	128

C 8634	M. L. Hatfield	Vol #:	128

C 8635	M. Gillis	Vol #:	128

C 8636	J. E. Boyd	Vol #:	128

C 8637	B. O'Donnell	Vol #:	128

C 8638	B. McCollum	Vol #:	128

C 8639	R. Pharm	Vol #:	128

C 8640	B. J.Schneider	Vol #:	128

C 8641	C. Ciaccio	Vol #:	128

C 8642	K. Anthes	Vol #:	128

C 8643	D. A. Scheyer	Vol #:	128

C 8644	R. Snyder	Vol #:	128

C 8645	T. Brooks	Vol #:	128

C 8646	C. Chapman	Vol #:	128

C 8647	L. Libby	Vol #:	128

C 8648	P. Enger	Vol #:	128

C 8649	K. Glidden	Vol #:	128

C 8650	L. K. Bradak	Vol #:	128

C 8651	J. R. Kelsey	Vol #:	128

C 8652	B. Bennett	Vol #:	128

C 8653	C. Boone	Vol #:	128

C 8654	K. K. Marshall	Vol #:	128

C 8655	K. Hauser	Vol #:	128

C 8656	L. A. Schroeder, M.D.	Vol #:	128

C 8657	C. Owens	Vol #:	128

C 8658	J. Stevens	Vol #:	128

C 8659	P. Kreher	Vol #:	128

C 8660	R. B. Navarro	Vol #:	128

C 8661	H. Wirth	Vol #:	128

C 8662	B. J. Schneider	Vol #:	128

C 8663	M. Stoor	Vol #:	128

C 8664	C. Jones	Vol #:	128

C 8665	G. W. Smith	Vol #:	128

C 8666	A. Parry	Vol #:	128

C 8667	M. Wiswell	Vol #:	128

C 8668	M. Greenstien	Vol #:	128

C 8669	S. Burnett	Vol #:	128



2006D-0083	Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

EC 1	Campbell University	Vol #:	1

2006D-0169	Guidance for Industry: Guidance on the labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Availability

EC 1	Mrs. Lisa mcdaniel	Vol #:	1

EC 2	Mrs. Shonna Alva	Vol #:	1

2006N-0045	Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT); Public Workshop; Request for Comments

EC 1	ARC Blood Services Technical Writer 1994-2002	Vol #:	1

2006P-0101	Petition for Review of Codex Standard for Honey Under 21 CFR 130.6

EC 1	Mr. G. Goodlett	Vol #:	1

2006P-0124	Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules

EC 1	Consumer	Vol #:	1

EC 2	Mr. feizhou nie	Vol #:	1

EC 3	Mr. Peter Sassi	Vol #:	1

EC 4	Ms. Kay Boluda	Vol #:	2

EC 5	Mr. John Calsin	Vol #:	1

EC 6	Mr. Orrrin Turbow	Vol #:	1

EC 7	Hines	Vol #:	1

EC 8	Roche	Vol #:	1

EC 9	Mr. Ryan Thompson	Vol #:	1

EC 10	Consumer	Vol #:	1

EC 11	Mr. Dave Lowe	Vol #:	1

EC 12	Mr. Juan Antonio Flores	Vol #:	1

2006P-0126	Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".

EC 1	Ms. Molly Johnson	Vol #:	2

EC 2	Ms. Nadine Saunders	Vol #:	2

EC 3	Congregation Beth Am	Vol #:	2

EC 4	Ms. Meme Tunnell	Vol #:	2

EC 5	Ms. Joanne Caravas	Vol #:	2

EC 6	Puget Sound Pug Dog Club, Inc.	Vol #:	2

EC 7	Mrs. Rose Ward	Vol #:	2

EC 8	Miss. Michele Seidman	Vol #:	2

EC 9	Mrs. Lesa Hershberger	Vol #:	2

EC 10	Mrs. Ellen Filarski	Vol #:	2

EC 11	Miss. Heather Miller	Vol #:	2



EC 12	Mrs. Sharon Alcalay	Vol #:	2

EC 13	Ms. Jillian Lopez	Vol #:	2

EC 14	Ms. Angie kirby	Vol #:	2

EC 15	Mr. Gilbert Wright	Vol #:	2

EC 16	Ms. Joyce Holbrook	Vol #:	2

EC 17	Mr. Wayne Brown	Vol #:	2

EC 18	Mr. Kim McKee	Vol #:	2

EC 19	Mrs. nancy schroeder	Vol #:	2

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

EC 1	Mrs. Dina Pastor	Vol #:	1

2006P-0173	Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product


EC 1	Mr. Dave Lowe	Vol #:	1

2006V-0194	Laser Light Show

ACK 1	FDA/ DDM to Funzalosound	Vol #:	1

VAR 1	Funzalosound	Vol #:	1

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FDA/Dockets Management